Trial Outcomes & Findings for The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane (NCT NCT01757561)

Results Overview

SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2\<50%.

Recruitment status

COMPLETED

Target enrollment

144 participants

Primary outcome timeframe

baseline ,every hour in the operation period,after extubation

Results posted on

2015-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Propofol-Abnormal patients with preoperative SjvO2\<55% propofol: use total intravenous anesthesia with propofol	Propofol-Normal patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol	Sevoflurane-Abnormal patients with preoperative SjvO2\<55% sevoflurane: use inhalation anesthesia with sevoflurane	Sevoflurane-Normal patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane
Overall Study STARTED	38	34	38	34
Overall Study COMPLETED	32	28	31	25
Overall Study NOT COMPLETED	6	6	7	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol-Abnormal n=32 Participants patients with preoperative SjvO2\<55% propofol: use total intravenous anesthesia with propofol	Propofol-Normal n=28 Participants patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol	Sevoflurane-Abnormal n=31 Participants patients with preoperative SjvO2\<55% sevoflurane: use inhalation anesthesia with sevoflurane	Sevoflurane-Normal n=25 Participants patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane	Total n=116 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 7.6 • n=5 Participants	69 years STANDARD_DEVIATION 10.5 • n=7 Participants	64.2 years STANDARD_DEVIATION 8.3 • n=5 Participants	67.2 years STANDARD_DEVIATION 8.5 • n=4 Participants	65.7 years STANDARD_DEVIATION 8.6 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	38 Participants n=21 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants	17 Participants n=4 Participants	78 Participants n=21 Participants
ASA ASAⅡ	30 participants n=5 Participants	22 participants n=7 Participants	23 participants n=5 Participants	17 participants n=4 Participants	92 participants n=21 Participants
ASA ASA Ⅲ	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants	8 participants n=4 Participants	24 participants n=21 Participants

PRIMARY outcome

Timeframe: baseline ,every hour in the operation period,after extubation

SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2\<50%.

Outcome measures

Outcome measures
Measure	Propofol-Abnormal n=32 Participants patients with preoperative SjvO2\<55% propofol: use total intravenous anesthesia with propofol	Propofol-Normal n=28 Participants patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol	Sevoflurane-Abnormal n=31 Participants patients with preoperative SjvO2\<55% sevoflurane: use inhalation anesthesia with sevoflurane	Sevoflurane-Normal n=25 Participants patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane
the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia	17 participants	6 participants	6 participants	0 participants

SECONDARY outcome

Timeframe: 1-3days、5-7days after operation

The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.

Outcome measures

Outcome measures
Measure	Propofol-Abnormal n=32 Participants patients with preoperative SjvO2\<55% propofol: use total intravenous anesthesia with propofol	Propofol-Normal n=28 Participants patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol	Sevoflurane-Abnormal n=31 Participants patients with preoperative SjvO2\<55% sevoflurane: use inhalation anesthesia with sevoflurane	Sevoflurane-Normal n=25 Participants patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane
the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia 1--3days after operation	9 participants	4 participants	4 participants	8 participants
the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia 5-7 days after operation	5 participants	2 participants	4 participants	4 participants

SECONDARY outcome

Timeframe: before anesthesia, after extubation ,1day after operation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before anesthesia,after extubation,1 day after operation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline , evey hour in the operation,afte extubation

heart rate, artery blood pressure,pulse oxygen saturation,temperature

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline,every hour in the operation,after extubation

including artery blood and blood from jugular vein bulb

Outcome measures

Outcome data not reported

Adverse Events

Propofol-Abnormal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Propofol-Normal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sevoflurane-Abnormal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sevoflurane-Normal

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Propofol-Abnormal n=38 participants at risk patients with preoperative SjvO2\<55% propofol: use total intravenous anesthesia with propofol	Propofol-Normal n=34 participants at risk patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol	Sevoflurane-Abnormal n=38 participants at risk patients with preoperative SjvO2\<55% sevoflurane: use inhalation anesthesia with sevoflurane	Sevoflurane-Normal n=34 participants at risk patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane
Cardiac disorders heart failure	0.00% 0/38 • the day of surgery and 1 week after surgery	0.00% 0/34 • the day of surgery and 1 week after surgery	0.00% 0/38 • the day of surgery and 1 week after surgery	0.00% 0/34 • the day of surgery and 1 week after surgery
Respiratory, thoracic and mediastinal disorders pulmonary edema	0.00% 0/38 • the day of surgery and 1 week after surgery	0.00% 0/34 • the day of surgery and 1 week after surgery	0.00% 0/38 • the day of surgery and 1 week after surgery	0.00% 0/34 • the day of surgery and 1 week after surgery

Other adverse events

Other adverse events
Measure	Propofol-Abnormal n=38 participants at risk patients with preoperative SjvO2\<55% propofol: use total intravenous anesthesia with propofol	Propofol-Normal n=34 participants at risk patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol	Sevoflurane-Abnormal n=38 participants at risk patients with preoperative SjvO2\<55% sevoflurane: use inhalation anesthesia with sevoflurane	Sevoflurane-Normal n=34 participants at risk patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane
Immune system disorders allergy	2.6% 1/38 • Number of events 1 • the day of surgery and 1 week after surgery	0.00% 0/34 • the day of surgery and 1 week after surgery	0.00% 0/38 • the day of surgery and 1 week after surgery	5.9% 2/34 • Number of events 2 • the day of surgery and 1 week after surgery

Additional Information

Juan-ying Guo

FirstSunYetSen

Phone: 8602087755766(8273)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place